Oral Health Education for Older Adults: Intentionality in Action

Официальное название

Exploring the Effectiveness of the Intentionality the Matrix of Healing in Enhancing Oral Health Education Outcomes for Community-dwelling Middle-aged and Older

Обзор

After obtaining approval from the Institutional Review Board (IRB), the clinical trial will be registered on a designated trial registration website. Participant recruitment will be conducted online. For individuals who meet the inclusion criteria and express interest, the principal investigator will verbally explain the study protocol, go over the informed consent form, and answer any related questions. Potential participants who meet the inclusion criteria and are willing to participate will be given time to consider their involvement in the study. Inclusion criteria for this study are: 1. Adults aged 40 and older 2. Ability to hear, speak, and read Chinese, and communicate fluently in Mandarin or Taiwanese. Exclusion criteria include: 1. Being completely edentulous and not using dentures; 2. Having severe food allergies, renal failure, or dysphagia; 3. Being diagnosed with terminal illness under palliative care, severe mental illness, or cognitive impairment; 4. Having a serious health condition that prevents standing or performing oral self-care behaviors. Upon receiving verbal agreement from potential participants, the study procedure and the contents of the consent form will be explained again. This is a parallel randomized experimental study, with an estimated sample of 90 middle-aged and older adults recruited from the community through online means. Participants will be randomly assigned to one of three groups: 1. intentional interviews combined with expressive arts activities, 2. expressive arts activities only, or 3. control group. All three groups will receive oral health education before the intervention and six weeks after the intervention. Questionnaire surveys will be conducted one week and one month post-education to collect data on sarcopenia risk, eating assessment, grit, oral health literacy, and oral self-care behaviors. Statistical analyses will be performed on the collected data. Participants who fully understand the study and agree to participate will sign an informed consent form. Two copies of the consent form will be prepared-one will be kept by the principal investigator, and a photocopy will be given to the participant for personal recordkeeping. Participants retain the right to decline or withdraw from the study at any time, even after signing the consent form. Their withdrawal will not affect their future rights, benefits, or services, and any previously collected data will be deleted upon request.

Вмешательства

• Поведенческое Intentional Interview
  Participants in this arm will receive an intervention
• Поведенческое Expressive Arts Activities
  Participants in this arm will engage only in expressive arts activities over a 6-week period.

Первичные конечные точки

• sarcopenia risk [Срок оценки: baseline, one week after the intervention, and at a one-month follow-up]
• eating assessment [Срок оценки: baseline, one week after the intervention, and at a one-month follow-up]
• grit [Срок оценки: baseline, one week after the intervention, and at a one-month follow-up]
• oral health literacy [Срок оценки: baseline, one week after the intervention, and at a one-month follow-up]
• oral self-care behaviors [Срок оценки: baseline, one week after the intervention, and at a one-month follow-up]

Критерии участия

Критерии включения

• Individuals aged 40 years or older (Vlietstra et al., 2024).
• Ability to hear, speak, and read Chinese, with no communication barriers in Mandarin or Taiwanese.

Критерии исключения

• Edentulous individuals who do not use dentures.
• Individuals with severe food allergies, renal failure, or dysphagia.
• Individuals diagnosed with terminal illness under palliative care, severe psychiatric disorders, or cognitive impairments.
• Individuals with serious medical conditions that prevent standing or performing oral self-care behaviors.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Тайвань · 1 центр

• Sanzhi — New Taipei City

Идентификаторы

NCT: NCT07265726 · 25MMHIS120e

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗